Registration with the ANVISA/MS in Brazil

According to the Brazilian sanitary legislation all products subject to health regulations are regulated by the National Health Surveillance Agency (ANVISA).

The health legislation in Brazil, as well as the classification schemes for medical products are similar to those found in the directive MDD 93/42/ECC European. The first step in the process of registering a determined product is determine their classification. This procedure is necessary because it will ensure that the product is framed within what preconize the legislation. Thus, being the classification confirmed, our team of specialized consultants will initiate the execution of the dossier and later submission of the lawsuit of the registration with the ANVISA.

Among the various services offered, we highlight:

• • Elaboration, Assembly, Accompaniment and Protocol of the Registration Process of Foods, Health Products (related), Medicaments, Cosmetics, Hygiene Products, Perfumes, Sanitizing Household Cleaning Products and Tobacco Derivatives;
  • Elaboration, Assembly, Accompaniment and Protocol of the Revalidation Process of Foods, Health Products (related), Medicaments, Cosmetics, Hygiene Products, Perfumes, Sanitizing Household Cleaning Products and Tobacco Derivatives;
  • Elaboration, Assembly, Accompaniment and Protocol of Alteration Process Post-Registration of Food, Health Products (related), Medicaments, Cosmetics, Hygiene Products, Perfumes, Sanitizing Household Cleaning Products and Tobacco Derivatives;
  • Revision of the Registration Dossier, Revalidation, Alteration Post-Registration of Food, Health Products (related), Medicaments, Cosmetics, Hygiene Products, Perfumes, Sanitizing Household Cleaning Products and Tobacco Derivatives;
  • Survey/Collect/Evaluation of informations and documents required by the health legislation
  • Elaboration of technical judgement – Health Framework;
  • Accompaniment of deadlines for purposes of the record revalidation.

In the case of the products classified in the area of medical products, if your company has a CE marking or the release of the US FDA 510(k), the informations contained in these files will be able to satisfy most of the demands requested for the approval of registration with the ANVISA in Brazil.

If your medical product is powered by an electrical power source will be necessary to obtain Certification of equipment from the INMETRO, by an authorized testing laboratory in Brazil.

The process of a record releasing in Brazil will depend a lot on the category in which it is framed (food, medicament, sanitizing ,medical product, IVD, tobacco derivatives) and may vary from 6 months to 2 years in the case of a pharmaceutical product.

Contact us for more information about how to register your medical device with the ANVISA.